Molecular Landscape and Validation of New Genomic Classification in 2668 Adult AML Patients: Real Life Data from the PETHEMA Registry
Next–Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has establis...
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| Published in | Cancers Vol. 15; no. 2; p. 438 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Switzerland
MDPI AG
10.01.2023
MDPI |
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| Online Access | Get full text |
| ISSN | 2072-6694 2072-6694 |
| DOI | 10.3390/cancers15020438 |
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| Abstract | Next–Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has established the first nationwide diagnostic network of seven reference laboratories to provide standardized NGS studies for AML patients. Cross–validation (CV) rounds are regularly performed to ensure the quality of NGS studies and to keep updated clinically relevant genes recommended for NGS study. The molecular characterization of 2856 samples (1631 derived from the NGS–AML project; NCT03311815) with standardized NGS of consensus genes (ABL1, ASXL1, BRAF, CALR, CBL, CEBPA, CSF3R, DNMT3A, ETV6, EZH2, FLT3, GATA2, HRAS, IDH1, IDH2, JAK2, KIT, KRAS, MPL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1 and WT1) showed 97% of patients having at least one mutation. The mutational profile was highly variable according to moment of disease, age and sex, and several co–occurring and exclusion relations were detected. Molecular testing based on NGS allowed accurate diagnosis and reliable prognosis stratification of 954 AML patients according to new genomic classification proposed by Tazi et al. Novel molecular subgroups, such as mutated WT1 and mutations in at least two myelodysplasia–related genes, have been associated with an adverse prognosis in our cohort. In this way, the PETHEMA cooperative group efficiently provides an extensive molecular characterization for AML diagnosis and risk stratification, ensuring technical quality and equity in access to NGS studies. |
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| AbstractList | Next-Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has established the first nationwide diagnostic network of seven reference laboratories to provide standardized NGS studies for AML patients. Cross-validation (CV) rounds are regularly performed to ensure the quality of NGS studies and to keep updated clinically relevant genes recommended for NGS study. The molecular characterization of 2856 samples (1631 derived from the NGS-AML project; NCT03311815) with standardized NGS of consensus genes (
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) showed 97% of patients having at least one mutation. The mutational profile was highly variable according to moment of disease, age and sex, and several co-occurring and exclusion relations were detected. Molecular testing based on NGS allowed accurate diagnosis and reliable prognosis stratification of 954 AML patients according to new genomic classification proposed by Tazi et al. Novel molecular subgroups, such as mutated
and mutations in at least two myelodysplasia-related genes, have been associated with an adverse prognosis in our cohort. In this way, the PETHEMA cooperative group efficiently provides an extensive molecular characterization for AML diagnosis and risk stratification, ensuring technical quality and equity in access to NGS studies. Next–Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has established the first nationwide diagnostic network of seven reference laboratories to provide standardized NGS studies for AML patients. Cross–validation (CV) rounds are regularly performed to ensure the quality of NGS studies and to keep updated clinically relevant genes recommended for NGS study. The molecular characterization of 2856 samples (1631 derived from the NGS–AML project; NCT03311815) with standardized NGS of consensus genes (ABL1, ASXL1, BRAF, CALR, CBL, CEBPA, CSF3R, DNMT3A, ETV6, EZH2, FLT3, GATA2, HRAS, IDH1, IDH2, JAK2, KIT, KRAS, MPL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1 and WT1) showed 97% of patients having at least one mutation. The mutational profile was highly variable according to moment of disease, age and sex, and several co–occurring and exclusion relations were detected. Molecular testing based on NGS allowed accurate diagnosis and reliable prognosis stratification of 954 AML patients according to new genomic classification proposed by Tazi et al. Novel molecular subgroups, such as mutated WT1 and mutations in at least two myelodysplasia–related genes, have been associated with an adverse prognosis in our cohort. In this way, the PETHEMA cooperative group efficiently provides an extensive molecular characterization for AML diagnosis and risk stratification, ensuring technical quality and equity in access to NGS studies. Simple SummaryNext–Generation Sequencing (NGS) has provided a deeper genetic understanding of acute myeloid leukemia (AML) that has been recently incorporated into AML classification and risk–stratification guidelines. Single molecular analysis has become inefficient and molecular testing based on NGS is emerging as an irreplaceable diagnostic tool in clinical settings. The PETHEMA cooperative group has constituted a nationwide NGS network with centralized analysis in seven high–skilled laboratories. The study of molecular profiles in the “real–life” PETHEMA cohort supports the increasing role of NGS on the clinical management of AML patients.AbstractNext–Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has established the first nationwide diagnostic network of seven reference laboratories to provide standardized NGS studies for AML patients. Cross–validation (CV) rounds are regularly performed to ensure the quality of NGS studies and to keep updated clinically relevant genes recommended for NGS study. The molecular characterization of 2856 samples (1631 derived from the NGS–AML project; NCT03311815) with standardized NGS of consensus genes (ABL1, ASXL1, BRAF, CALR, CBL, CEBPA, CSF3R, DNMT3A, ETV6, EZH2, FLT3, GATA2, HRAS, IDH1, IDH2, JAK2, KIT, KRAS, MPL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1 and WT1) showed 97% of patients having at least one mutation. The mutational profile was highly variable according to moment of disease, age and sex, and several co–occurring and exclusion relations were detected. Molecular testing based on NGS allowed accurate diagnosis and reliable prognosis stratification of 954 AML patients according to new genomic classification proposed by Tazi et al. Novel molecular subgroups, such as mutated WT1 and mutations in at least two myelodysplasia–related genes, have been associated with an adverse prognosis in our cohort. In this way, the PETHEMA cooperative group efficiently provides an extensive molecular characterization for AML diagnosis and risk stratification, ensuring technical quality and equity in access to NGS studies. Next-Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has established the first nationwide diagnostic network of seven reference laboratories to provide standardized NGS studies for AML patients. Cross-validation (CV) rounds are regularly performed to ensure the quality of NGS studies and to keep updated clinically relevant genes recommended for NGS study. The molecular characterization of 2856 samples (1631 derived from the NGS-AML project; NCT03311815) with standardized NGS of consensus genes (ABL1, ASXL1, BRAF, CALR, CBL, CEBPA, CSF3R, DNMT3A, ETV6, EZH2, FLT3, GATA2, HRAS, IDH1, IDH2, JAK2, KIT, KRAS, MPL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1 and WT1) showed 97% of patients having at least one mutation. The mutational profile was highly variable according to moment of disease, age and sex, and several co-occurring and exclusion relations were detected. Molecular testing based on NGS allowed accurate diagnosis and reliable prognosis stratification of 954 AML patients according to new genomic classification proposed by Tazi et al. Novel molecular subgroups, such as mutated WT1 and mutations in at least two myelodysplasia-related genes, have been associated with an adverse prognosis in our cohort. In this way, the PETHEMA cooperative group efficiently provides an extensive molecular characterization for AML diagnosis and risk stratification, ensuring technical quality and equity in access to NGS studies.Next-Generation Sequencing (NGS) implementation to perform accurate diagnosis in acute myeloid leukemia (AML) represents a major challenge for molecular laboratories in terms of specialization, standardization, costs and logistical support. In this context, the PETHEMA cooperative group has established the first nationwide diagnostic network of seven reference laboratories to provide standardized NGS studies for AML patients. Cross-validation (CV) rounds are regularly performed to ensure the quality of NGS studies and to keep updated clinically relevant genes recommended for NGS study. The molecular characterization of 2856 samples (1631 derived from the NGS-AML project; NCT03311815) with standardized NGS of consensus genes (ABL1, ASXL1, BRAF, CALR, CBL, CEBPA, CSF3R, DNMT3A, ETV6, EZH2, FLT3, GATA2, HRAS, IDH1, IDH2, JAK2, KIT, KRAS, MPL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1 and WT1) showed 97% of patients having at least one mutation. The mutational profile was highly variable according to moment of disease, age and sex, and several co-occurring and exclusion relations were detected. Molecular testing based on NGS allowed accurate diagnosis and reliable prognosis stratification of 954 AML patients according to new genomic classification proposed by Tazi et al. Novel molecular subgroups, such as mutated WT1 and mutations in at least two myelodysplasia-related genes, have been associated with an adverse prognosis in our cohort. In this way, the PETHEMA cooperative group efficiently provides an extensive molecular characterization for AML diagnosis and risk stratification, ensuring technical quality and equity in access to NGS studies. |
| Author | Serrano, Josefina Larráyoz, María José Herrera-Puente, Pilar Pérez-Simón, José Antonio Prados de la Torre, Esther Boluda, Blanca Martínez-López, Joaquín Rodríguez-Veiga, Rebeca Sayas, María José Algarra, Lorenzo Bernal, Teresa Carrillo-Cruz, Estrella Bergua, Juan Miguel Bilbao-Sieyro, Cristina Sargas, Claudia Alonso-Domínguez, Juan Manuel Amigo, María Luz Martínez-Sánchez, Pilar Sánchez-García, Joaquín Tormo, Mar Soria, Elena Ayala, Rosa Gómez-Casares, María Teresa Martínez-Cuadrón, David Gil, Cristina Lavilla-Rubira, Esperanza Chillón, María Carmen García-Boyero, Raimundo García-Sanz, Ramón Montesinos, Pau Calasanz, María José Barragán, Eva |
| AuthorAffiliation | 18 Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain 16 Hospital Universitario General de Castellón, 12004 Castellón de la Plana, Spain 1 Grupo Acreditado de Investigación en Hematología, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain 17 Hospital Universitario Morales Messeguer, 30008 Murcia, Spain 12 Hospital Universitario San Pedro de Alcántara, 10003 Cáceres, Spain 7 Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), 14004 Córdoba, Spain 5 Hospital Universitario Virgen del Rocío, Instituto de Biomedicina (IBIS/CSIC/CIBERONC), Universidad de Sevilla, 41013 Sevilla, Spain 15 Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain 21 Servicio Análisis Clínicos, Grupo Acreditado de Investigación en Hematología, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain 10 Hospital General Universitario |
| AuthorAffiliation_xml | – name: 14 Hospital Clínico Universitario–INCLIVA, 46010 Valencia, Spain – name: 2 Hospital Universitario 12 de Octubre, National Cancer Research Center, Complutense University, 28041 Madrid, Spain – name: 6 Hospital Universitario de Gran Canaria Dr. Negrín, 35010 Las Palmas de Gran Canaria, Spain – name: 8 Servicio de Hematología, Grupo Acreditado de Investigación en Hematología, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain – name: 5 Hospital Universitario Virgen del Rocío, Instituto de Biomedicina (IBIS/CSIC/CIBERONC), Universidad de Sevilla, 41013 Sevilla, Spain – name: 21 Servicio Análisis Clínicos, Grupo Acreditado de Investigación en Hematología, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain – name: 11 Hospital Universitario Central de Asturias, Instituto Universitario (IUOPA), Instituto de Investigación del Principado de Asturias (ISPA), 33011 Oviedo, Spain – name: 7 Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), 14004 Córdoba, Spain – name: 15 Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain – name: 13 Hospital Universitario General de Albacete, 02006 Albacete, Spain – name: 17 Hospital Universitario Morales Messeguer, 30008 Murcia, Spain – name: 18 Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain – name: 20 Complexo Hospitalario Lucus Augusti, 27003 Lugo, Spain – name: 3 CIMA LAB Diagnostics, Departamento de Bioquímica y Genética, Universidad de Navarra, 31008 Pamplona, Spain – name: 4 Servicio de Hematología, Hospital Universitario de Salamanca (HUS/IBSAL), CIBERONC, Centro de Investigación del Cáncer–IBMCC (USAL–CSIC), 37007 Salamanca, Spain – name: 9 Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain – name: 19 Hospital Universitari Dr. Peset, 46017 Valencia, Spain – name: 1 Grupo Acreditado de Investigación en Hematología, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain – name: 10 Hospital General Universitario de Alicante, 03010 Alicante, Spain – name: 16 Hospital Universitario General de Castellón, 12004 Castellón de la Plana, Spain – name: 12 Hospital Universitario San Pedro de Alcántara, 10003 Cáceres, Spain |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36672386$$D View this record in MEDLINE/PubMed |
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| Copyright | 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2023 by the authors. 2023 |
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| Keywords | acute myeloid leukemia cross–validations genomic classification clinical validation Next–Generation Sequencing mutational profile |
| Language | English |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 These authors contributed equally to this work. The consortium members are listed in Appendix A. |
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| PublicationTitle | Cancers |
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| PublicationYear | 2023 |
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| SubjectTerms | Acute myeloid leukemia Classification Diagnosis Genes Genomics Janus kinase 2 Laboratories Leukemia Medical prognosis Mutation Myelodysplastic syndrome p53 Protein Prognosis Quality control Runx1 protein Standardization |
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| Title | Molecular Landscape and Validation of New Genomic Classification in 2668 Adult AML Patients: Real Life Data from the PETHEMA Registry |
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